BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMERAL STEM, 6MM

    MDR report key: 1202758 · Received October 10, 2008

    Report

    Report Number
    1220246-2008-00211
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION, BUT IT WAS REPORTED THAT IT WAS SENT OUT BY THE HOSPITAL TO A LABORATORY FOR TESTING FOR BACTERIA. THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED; THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE LOT NUMBER WAS ALSO REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY COULD NOT BE CONDUCTED WITHOUT LOT NUMBER. NOT ENOUGH INFORMATION WAS PROVIDED TO DETERMINE A POSSIBLE CAUSE FOR THE EVENT. A CASE CLOSURE SUMMARY IS BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A SURGEON WAS PERFORMING A ROTATOR CUFF REPAIR, HE FOUND THE SET SCREW OR THE TRUNION (OF A PREVIOUS TOTAL SHOULDER IMPLANT) HAD COME LOOSE. THE SURGEON REMOVED THE DEVICE IN 3 PIECES. ANOTHER DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED AS DOING FINE. THE ORIGINAL IMPLANT DATE WAS REPORTED AS 3-4 YEARS AGO. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATIONS. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL STEM, 6MM KWS ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other INFORMATION REQUESTED BUT NOT PROVIDED.